Variable KV Intrex VSK 60 - 90 KVP

FDA 510(k) K883354 · Keystone X-Ray, Inc.

Substantially Equivalent

510(k) numberK883354

Submission

Device name
Variable KV Intrex VSK 60 - 90 KVP
Applicant
Keystone X-Ray, Inc.
Neptune Township, NJ, US
Received
August 9, 1988
Decision date
December 21, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EAP – Unit, X-Ray, Intraoral
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1810
Specialty
Dental

Other 510(k)s with product code EAP

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K113360Medical Image Processing UnitEAP · Special Humanray Co,Ltd02/07/2012SE
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K093453Modification to Computed Oral Radiology SystemEAP · Special Schick Technologies, Inc.11/30/2009SE
K080738Dentron SensorEAP · Traditional Dentron Systems, LLC05/13/2008SE
K052422The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)EAP · Special Flow X-Ray Corp.09/27/2005SE
K041385Modification to Computed Oral Radiology SystemEAP · Special Schick Technologies, Inc.06/07/2004SE
K960819Heliodent DSEAP · Traditional Pelton & Crane Co.03/29/1996SE
K960028Orthoralix SD2 & S Panoramic Dental X-Ray SystemEAP · Traditional Dentsply Intl.03/01/1996SE
K953936AtlantisEAP · Traditional Trophy Radiologie12/28/1995SE
K954565Explor-X (Azteh) HFEAP · Traditional Chicago X-Ray Systems, Inc.10/27/1995SE

More from Chicago X-Ray Systems, Inc.

510(k)DeviceDecision
K931486Intrex VSK Interoral Dental X-Ray UnitEAP · Traditional 11/23/1993SE
K930925Intrex Interoral Dental X-Ray UnitEAP · Traditional 07/13/1993SE
K812217Fluoro Automatic Brightness SysJAA · Traditional 09/16/1981SE

Questions and answers

When was Variable KV Intrex VSK 60 - 90 KVP cleared by the FDA?

Variable KV Intrex VSK 60 - 90 KVP (K883354) received a 510(k) decision of Substantially Equivalent on December 21, 1988, 134 days after the submission was received.

What is the product code of K883354?

The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.